MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 7X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231800
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part (231800) - lot number (l347171) combination as per qlik query executed 05/10/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a biceps tenodesis procedure the customer's 7x23mm milagro interference screw was inserted into the patient, but was sitting proud.The screw was fully removed with no debris left behind.The sales rep stated that the surgeon drilled a size eight tunnel and followed the sizing technique.The sales rep stated that the sutures were pulled during the case and the patient's bicep ruptured near the socket.The case was not completed and there is no plan for future surgical intervention.The milagro screw was discarded by the customer.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8608788
• Report Number: 1221934-2019-57140
• Device Sequence Number: 19381496
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 231800
• Device Lot Number: L347171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1